The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Dispenser, Gas Xenon.
| Device ID | K781107 |
| 510k Number | K781107 |
| Device Name: | DISPENSER, GAS XENON |
| Classification | System, Rebreathing, Radionuclide |
| Applicant | MALLINCKRODT CRITICAL CARE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IYT |
| CFR Regulation Number | 892.1390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-06-30 |
| Decision Date | 1978-07-17 |